MAUDE Adverse Event Report: COOK INC LIVER ACCESS AND BIOPSY SET; FCG KIT, NEEDLE, BIOPSY

Model Number	G50779
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: risk management.G4 ¿ pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional.Relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective ormalfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported that the distal tip of the black catheter included in the liver access and biopsy set sheared off during biopsy procedure.The white hub of the catheter detached from black part when the physician attempted to advance the outer catheter into position for the biopsy.This occurred again when a second new catheter was used.In the first catheter, the distal end of the black inner catheter sheared off inside the blue outer catheter during an attempt to remove it along the wire.The distal end remained inside the blue outer catheter and compromised the ability to obtain samples.It was also reported that there was no harm to the patient and procedure was completed successfully.This report captures tip separation from the straight black catheter.Hub detachment from the straight black catheter is referenced in a report with the patient identifier: (b)(6).
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported that the distal tip of the black catheter included in the liver access and biopsy set sheared off during biopsy procedure.The white hub of the catheter detached from black part when the physician attempted to advance the outer catheter into position for the biopsy.This occurred again when a second new catheter was used.In the first catheter, the distal end of the black inner catheter sheared off inside the blue outer catheter during an attempt to remove it along the wire.The distal end remained inside the blue outer catheter and compromised the ability to obtain samples.It was also reported that there was no harm to the patient and procedure was completed successfully.Reviews of the documentation, including the complaint history, device history record (dhr), quality control procedures, specifications and instructions for use (ifu), as well as visual inspection, functional test and dimensional verification of the returned product, were conducted during the investigation.One used set was received along with a second black catheter.One of the catheters was sheared near the distal tip.A compression was also noted in the shaft of the catheter.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for the device found no relevant nonconformance's that could have contributed to the reported failure mode.It should be noted that there was one other complaint associated with the final product lot number.Cook also reviewed product labeling: the product ifu, [t_labs_rev7] ¿liver access and biopsy set,¿ provides the following information to the user related to the reported failure mode: ¿instructions for use: using a selective catheter and wire guide of choice, catheterize the right hepatic vein or an appropriate alternative hepatic vein branch.Leave the wire in a safe, distal position, and remove the catheter.Caution: to prevent cardiac arrhythmias, continuous cardiac monitoring is recommended while negotiating past the right atrium.Introduce and advance the transjugular introducer sheath and stiffening cannula over the wire guide into the selective hepatic vein.When introducing these components as a preassembled set, the included straight catheter may be used to facilitate introduction.Once the set is positioned within the hepatic vein, the straight catheter should be removed.Note: care should be taken to prevent damage to the straight catheter during removal through the metal stiffening cannula.Leaving a wire guide through the straight catheter during removal may aid in preventing catheter damage.¿ evidence gathered upon review of the dmr, product ifu, dhr, and device failure analysis, there is no indication the complaint device was manufactured out of specification.Cook did not identify any nonconforming material in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.It¿s possible that as the catheter was being withdrawn through the metal cannula, it sheared and came off inside the blue outer catheter.However, this cannot be confirmed without additional information.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: LIVER ACCESS AND BIOPSY SET
• Common Device Name: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 19973241
• Report Number: 1820334-2024-01078
• Device Sequence Number: 15561562
• Product Code: FCG
• UDI-Device Identifier: 00827002507791
• UDI-Public: (01)00827002507791(17)270416(10)16010488
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G50779
• Device Catalogue Number: LABS-100-J
• Device Lot Number: 16010488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown